Food additives: Steviol glycosides
- Food additives
- Food safety
Summary
The European Union (EU) has updated the specifications for rebaudioside M (E 960c(ii)), a sweetener, to allow its production using enzymes produced by the genetically modified (GM) yeast strain K. phaffii CGMCC 7539.
EU updates its production specification for the steviol glycoside sweetener rebaudioside M, allowing the use of specific GM yeast enzymes from 8 November 2026
Commission Regulation (EU) 2026/2309 of 16 October 2026 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council, as regards specifications for enzymatically produced steviol glycosides to include rebaudioside M produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extract (E 960c(ii)) using the genetically modified yeast K. phaffii CGMCC 7539
Update
The European Union (EU) has updated the specifications for rebaudioside M (E 960c(ii)), a sweetener, to allow its production using enzymes produced by the genetically modified (GM) yeast strain K. phaffii CGMCC 7539.
Impacted Products
Sweeteners (steviol)
What is changing?
Rebaudioside M
The EU has updated the production specifications for rebaudioside M (E 960c(ii)), a stevia-based sweetener, to allow its production using enzymes produced by a new genetically modified yeast strain, K. phaffii CGMCC 7539 (Regulation 2026/2309). For kaurenoic acid, a substance that may be present as an impurity, it has introduced a limit of 0.3 mg/kg.
Steviol glycosides from fermentation
In 2025, the EU authorised the use of steviol glycosides made from rebaudioside M produced by fermentation using Yarrowia lipolytica (E 960b) as a food additive for sweetening purposes (Regulation 2025/652). This additive is included in the existing group of steviol glycosides (E 960a–960d), meaning that it can be used in the same food categories as those additives and at the same maximum levels (see Regulation 2023/447). As the production of steviol glycosides from fermentation may lead to different impurities from other steviol glycosides, separate specifications are established in Annex II of the Regulation.
Why?
The European Food Safety Authority has concluded that there is no safety concern related to rebaudioside M produced using enzymes from the genetically modified yeast strain K. phaffii CGMCC 7539 (EFSA 2025).
Timeline
This authorisation of rebaudioside M produced using enzymes from the GM yeast strain K. phaffii CGMCC 7539 applies from 8 November 2026.
Background
The EU approves food additives and sets out their conditions of use. The list of approved food additives can be updated on request by the EU, or following an application.
Steviol glycosides obtained by four different manufacturing processes are regulated in combination as food additives (Regulation 1333/2008, Annex II, Part C) with maximum limits expressed as steviol equivalents. The other authorised steviol glycosides are:
- steviol glycosides from Stevia (E 960a)
- steviol glycosides from fermentation (E 960b)
- enzymatically produced steviol glycosides (E 960c)
- glucosylated steviol glycosides (E 960d).
For the most recently updated list of approved food additives and conditions of use, see Regulation 1333/2008: click on the date that follows “Current consolidated version”.
Resources
EFSA (2023) Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Yarrowia lipolytica VRM. EFSA Journal, 21: e8387.
EFSA (2025) Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii). EFSA Journal, 23(5): 9396.
Regulation 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
Regulation 1333/2008 on food additives
Sources
Commission Regulation (EU) 2026/2309 […] as regards specifications for enzymatically produced steviol glycosides to include rebaudioside M produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extract (E 960c(ii)) using the genetically modified yeast K. phaffii CGMCC 7539
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.
EU updates its production specification for the steviol glycoside sweetener rebaudioside M, allowing the use of specific GM yeast enzymes from 8 November 2026
Commission Regulation (EU) 2026/2309 […] as regards specifications for enzymatically produced steviol glycosides to include rebaudioside M produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extract (E 960c(ii)) using the genetically modified yeast K. phaffii CGMCC 7539
What is changing and why?
The European Union (EU) has updated the production specifications for rebaudioside M (E 960c(ii)), a stevia-based sweetener, to allow the use of enzymes produced by the genetically modified yeast strain K. phaffii CGMCC 7539 in its production. This follows an assessment by the European Food Safety Authority. For kaurenoic acid, a substance that may be present as an impurity, a limit of 0.3 mg/kg has been introduced.
Timeline
This authorisation applies from 8 November 2026.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.